Kornimate/medical-research-clean huggingface dataset:
facilitating accelerated clinical validation of novel diagnostics for covid-19 (falcon-c19)

Conditions: Coronavirus Infection; COVID-19

Summary: the united kingdom and wider world is in the midst of the 2019 novel coronavirus (sars-cov-2) pandemic. accurate diagnosis of infection, identification of immunity and monitoring the clinical progression of infection are of paramount importance to our response. widespread population testing has proven difficult in western countries and has been limited by test availability, human resources and long turnaround times (up to 72 hours). this has limited our ability to control the spread of infection and to develop effective clinical pathways to enable early social isolation of infected patients and early treatment for those most at risk. the life sciences industry has responded to the pandemic by developing multiple new in vitro diagnostic tests (ivds). to leverage the potential clinical benefit of those tests we require efficient but robust clinical evaluation. therefore, to optimise resource utilisation in this global pandemic, we will conduct a platform adaptive diagnostic study on a national level, utilising a national network of expertise in the evaluation of diagnostic technology. this study will enable the evaluation of multiple assays in three priority areas: 1. evaluation of the diagnostic accuracy of ivds for active infection with sars-cov-2 2. evaluation of assays monitoring the immune response to sars-cov-2 infection 3. evaluation of the prognostic value of commercially available tests for predicting prognosis in patients with suspected or confirmed sars-cov-2 infection. (this arm will not be active immediately but may be activated after initiation).


Eligibility criteria:
work stream a (in-hospital; group 1 and group 2): group 1 inclusion criteria: we will include participants (patients or staff): 1. that are 18 years or older 2. that will require testing for covid-19 in the opinion of the treating clinician 3. that may have presented with acute symptoms of covid-19 (e.g. fever, cough, dyspnoea, anosmia) or chest x-ray changes or they may be asymptomatic but require testing for other reasons group 2 inclusion criteria: we will include participants: 1. that are 18 years or older 2. that have been admitted for another reason other than suspected sars-cov-2 infection, but when routinely swabbed they have been identified as positive for sars-cov-2 pcr work stream b (group 3): we will include participants: 1. that are 18 years or older either: 2. they have been identified as positive for sars-cov-2 pcr through testing at national laboratory infrastructure or 3. they have been identified as negative for sars-cov-2 pcr through testing at national laboratory infrastructure work stream c (group 4): we will include participants: 1. that are 18 years or older 2. who are undergoing testing for covid-19, whether they are symptomatic or symptomatic for covid-19 exclusion criteria for all work streams: 1. patients where it is impossible/unsafe to obtain the required research samples 2. prisoners 3. patients where sampling is not feasible

Keywords: in vitro diagnostics point-of-care testing
safety and performance of electrodes implanted in the left ventricle

Conditions: Heart Failure; Ventricular Dysfunction; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Summary: the study is intended to demonstrate the safe implant of small receiver-electrodes into the endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac resynchronization therapy in heart failure patients.

eligible patients will undergo an acoustic window assessment using transthoracic echocardiography. patients with adequate acoustic windows will undergo implantation of the wics-lv system. patients will undergo evaluations pre-hospital discharge, and at one month, 3 months, and 6 months post implantation. extended follow-up will be obtained via a registry at 1, 2, 3, 4, and 5 years post implantation.

Eligibility criteria:
inclusion criteria: patients with standard indications for crt based upon the most recent esc/ehra guidelines and meeting criteria for one of these two categories: 1. patients with previously implanted pacemakers or icd's and meeting standard indications for crt but in whom standard crt is not advisable due to known high risk - referred to as "upgrades". justifications for not using standard crt must be documented in a crf. 2. patients in whom coronary sinus lead implantation or attempted implantation for crt has failed to provide demonstrable therapy benefit - referred to as "untreated" exclusion criteria: 1. inability to comply with the study follow-up or other study requirements 2. history of chronic alcohol/drug abuse and currently using alcohol/drugs 3. non-ambulatory (or unstable) nyha class 4 4. contraindication to heparin 5. contraindication to both chronic anticoagulants and antiplatelet agents 6. triple anticoagulation therapy (warfarin, clopidogrel, asa, and other agents) 7. thrombocytopenia (platelet count \<150,000) 8. contraindication to iodinated contrast agents 9. intracardiac thrombus by transesophageal echocardiography 10. age less than 18 years or greater than 75 11. attempted ipg implant within 3 days 12. life expectancy of less than 12 months 13. chronic hemodialysis 14. stage 4 or 5 renal dysfunction defined as gfr \<30 15. grade 4 mitral valve regurgitation 16. myocardial infarction within one month 17. major cardiac surgery within one month 18. history of a pericardial effusion in prior procedures 19. female of childbearing potential, pregnant, or breastfeeding (a pregnancy test will be obtained where applicable) 20. non-cardiac implanted electrical stimulation therapy devices

Keywords: cardiac resynchronization therapy cardiac pacing electrical stimulation bi-ventricular pacing
tdcs for the management of multiple sclerosis related fatigue

Conditions: Multiple Sclerosis

Summary: this is a pragmatic clinical trial that aims to determine the effect of tdcs on symptomatic fatigue in multiple sclerosis (ms) patients. this is a randomized, blinded, sham-controlled study design to determine the effect of transcranial direct current stimulation (tdcs) on ms participants to reduce feelings of fatigue.120 participants with ms and clinically-significant fatigue (as defined by a score of \>36 on the fatigue severity scale) will be recruited to participate in either an active or sham treatment condition.


Eligibility criteria:
inclusion criteria: * definite ms diagnosis, all subtypes * fatigue severity scale score of 36 or greater * score of 7.5 or less on the expanded disability status scale (edss) (with caregiver proxy required for those with scores of 7.5 or greater) * ability to understand the informed consent process and provide consent to participate in the study exclusion criteria: * primary neurologic, psychiatric or other medical disorder other than ms * history of seizures or seizure disorder * history of head trauma or medical device in head or neck * clinically significant abnormality on ekg * current symptomatic treatment for fatigue * symbol digit modalities test or sdmt score≥3.0 sd from published norms * wrat-4 reading level below average (\<85) (estimated general intellectual function) * beck depression inventory-fast screen (bdi- fs) score ≥10 * current chronic headaches or migraines * skin disorder/sensitive near stimulation locations
prevention through intervention: telehealth solution to deter 911 calls due to hypoglycemia

Conditions: Diabetes Mellitus; Hypoglycemia Unawareness; Hypoglycemia; Hypoglycemia Acute

Summary: this study aims to standardize and evaluate the benefits of the prevention to intervention program offered by the birmingham fire and rescue service. this will accomplished by standardizing the educational materials used, offering phone based follow-up and pre-post data collection.


Eligibility criteria:
inclusion criteria: 1. be a citizen of birmingham 2. be 18 years or older 3. receive dextrose-50 iv (intravenous treatment provided by ems personnel for hypoglycemia) 4. understand and speak english exclusion criteria: a) enrolled currently in any diabetes related educational programs

Keywords: telehealth emergency medicine paramedicine diabetes hypoglycemia telecoaching
neonatal seizure registry, genetics of post-neonatal epilepsy

Conditions: Neonatal Seizure; Hypoxic-Ischemic Encephalopathy; Stroke; Intracranial Hemorrhage; Epilepsy; Gene Abnormality

Summary: the nsr-gene study is a longitudinal cohort study of approximately 300 parent-child trios from the neonatal seizure registry and participating site outpatient clinics that aims to evaluate whether and how genes alter the risk of post-neonatal epilepsy among children with acute provoked neonatal seizures. the researchers aim to develop prediction rules to stratify neonates into low, medium, and high risk for post-neonatal epilepsy based on clinical, electroencephalogram (eeg), magnetic resonance imaging (mri), and genetic risk factors.

neonatal seizures due to brain injury (acute provoked seizures) are associated with high risk of post-neonatal epilepsy. although clinical risk factors can help predict which children are at highest risk for epilepsy, little is known about how genetic factors modify the risk for epilepsy after acute provoked neonatal seizures. the neonatal seizure registry - genetics of epilepsy (nsr-gene) study will test the central hypothesis that children who develop post-neonatal epilepsy are more likely to have pathogenic variants in epilepsy genes, and enrichment in single nucleotide polymorphisms within key inflammatory, neurotransmitter transport and homeostasis, and neurotrophic gene pathways as compared with children who do not develop unprovoked seizures before age five years, and that these can be added to traditional clinical risk factors to predict epilepsy after neonatal seizures.

Eligibility criteria:
inclusion criteria: * children \< 44 weeks postmenstrual age at seizure onset * seizures due to an acute provoked cause (including, but not limited to hie, ischemic stroke, or intracranial hemorrhage) * parent(s) who are english or spanish literate (with interpreter) * birthdate between 3/1/2023 and 1/1/2011 * one biological parent willing to participate * enrolled in nsr-ii * fulfilling all nsr-ii eligibility criteria and evaluated at an nsr center for neonatal seizures or enrolled in nsr-rise exclusion criteria: * risk for adverse outcome independent of seizures and underlying brain injury (including but not limited to inborn errors of metabolism, fetal infection, brain malformation) * transient cause for seizures (e.g., hypoglycemia without brain injury, hyponatremia, hypocalcemia) * neonatal-onset epilepsy syndromes * deceased
use of airtime amounts to improve interactive voice response surveys in colombia and tanzania

Conditions: Surveys and Questionnaires; Noncommunicable Diseases

Summary: this study evaluates the effect of three different airtime incentive amounts on interactive voice response (ivr) survey cooperation, response, refusal and contact rates, as compared to control group, in colombia and tanzania.

using random digit dialing (rdd) sampling technique, participants were randomized one of four airtime incentive amounts contingent on them completing the noncommunicable disease risk factor survey. this mobile phone survey will be sent as an interactive voice response (ivr). in ivr surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. if you are male, pres 1; if you are female, press 2). this study will be conducted in both colombia and tanzania.

Eligibility criteria:
inclusion criteria: * access to a mobile phone * greater or equal to 18 years of age * in colombia, conversant in the spanish language. in tanzania, conversant in the swahili language. exclusion criteria: * less than 18 years of age

Keywords: mobile phone surveys interactive voice response incentive
adipose derived regenerative cellular therapy of chronic wounds

Conditions: Diabetic Foot; Venous Ulcer; Pressure Ulcer

Summary: our study aims to explore the effects of adipose derived stem cells (ascs) on chronic wounds.

in an attempt to explore the contribution of adipose derived stem cells (ascs) to chronic wound healing, we will investigate the effects of injecting ascs into the periphery and debrided surfaces of chronic wounds. our goal is to achieve healing in two months, and for the wounds to stay healed for the following two weeks.

Eligibility criteria:
inclusion criteria: * female or male patient aged ≥ 18 * with diagnosis of diabetic or other chronic wound * grade 1 or 2 wound on the wagner scale * ulcer with a surface area comprised greater than 4 cm2 included (after mechanical debridement of the ulcer) * for subjects with more than one wound that meet these criteria, all qualifying wounds may be treated * patient's wound has been refractory to standard of care (no measureable signs of healing for at least 30 days) * patient has adequate (\>200cc) abdominal or other subcutaneous adipose tissue accessible by syringe-based lipoharvest * patient has activated platelet thromboplastin time (aptt) of \< 1.6x the mean normal reference interval at the time of the lipoharvest procedure and no contraindication to lipoharvest exclusion criteria: * typical charcot's foot * presence of osteitis (eq br osteomyelitis) at the inclusion visit (evidenced with a radiological lesion facing the wound \[bone erosion or disappearance of the cortical bone\]) as determined by mri * clinical evidence of uncontrolled infection at the inclusion visit * patient not eligible for syringe-based lipoharvest of at least 200cc of subcutaneous adipose tissue * subjects with cancerous or pre-cancerous lesions in the area to be treated * patient with working activity who cannot be on sick-leave during the study period * patient suffering from a psychiatric disorder not treated * clinical evidence of gangrene on any part of the affected foot * patient receiving corticosteroids, nsaids, immunosuppressive or cytotoxic agents, all systemic agents that can affect wound repair or any treatment that might interfere with the assessment of the study treatment * pregnant or nursing females * patient receiving dialysis for renal insufficiency or who have severe renal dysfunction * patient who cannot have an off-loading method * participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this study * any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study

Keywords: chronic wounds diabetes adipose derived stem cells diabetic foot
mri in predicting early response to chemotherapy in patients with locally advanced breast cancer

Conditions: Breast Cancer

Summary: rationale: diagnostic procedures such as mri scans may help predict early response to treatment in patients with breast cancer undergoing chemotherapy. purpose: this phase ii trial is studying mri in predicting early response to chemotherapy in patients with locally advanced breast cancer.

objectives: * to determine the technical feasibility of using mri in a multicenter setting using the most commonly available magnetic resonance (mr) systems (i.e., is the trial able to scan patients to a specific protocol, using different types of mri machine) measured by the number of mri scans not completed to technical specifications (i.e., incorrect sequences or incomplete scans) or trial protocol (i.e., scans not completed or completed at the wrong time). * to determine how reliably the imaging data can be analyzed in a centralized, semi-automated manner (i.e., can mri data be reliably transferred from different centers and analyzed using software based in the center for mr investigations at the university of hull) measured by the number of cases where automated data analysis of completed mri scans was not possible (i.e., data could not be analyzed at all or data required manual analysis). outline: this is a multicenter study. patients undergo magnetic resonance imaging (mri) scans at baseline, 4-7 days after beginning after the first course of chemotherapy, at the end of their second course of chemotherapy, and at the end of their fourth course of chemotherapy (first regimen). mri techniques may include dynamic contrast-enhanced, diffusion-weighted, and spectroscopic.

Eligibility criteria:
disease characteristics: * newly diagnosed, histologically proven breast cancer * stage t2-4b, n0-3c, and m0 disease * locally advanced primary disease * underwent both x-ray mammography and breast ultrasound scanning during the current treatment episode * scheduled for neoadjuvant chemotherapy patient characteristics: * not pregnant or nursing * medically stable * no renal failure * no serious breast trauma within the past 3 months * no known allergic reaction associated with previous administration of a paramagnetic contrast agent * no known contraindication to magnetic resonance (mr) scanning * must pass the normal safety requirements of mr, particularly pacemakers and cardiac defibrillators * no disability preventing mr scanning in the prone position * no body habitus incompatible with mr system entry prior concurrent therapy: * see disease characteristics * no prior chemotherapy * no prior surgery or radiotherapy for cancer in the ipsilateral breast * more than 4 months since prior surgery to the ipsilateral breast for benign breast disease

Keywords: stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer
myocardial perfusion echocardiography to detect human heart transplant rejection

Conditions: Heart Transplantation

Summary: the primary objective of this proposal is to show the efficacy of contrast enhanced ultrasonography in detecting heart transplant rejection in humans. the secondary objective is to demonstrate the efficacy of this technique in generating data which allow for the assessment of short and long term outcomes.


Eligibility criteria:
inclusion criteria: * all adult subjects (ages 18 to 75) who have undergone heart transplant at brigham and women's hospital exclusion criteria: * hemodynamic instability (e.g., systolic blood pressure \< 90 mmhg) * atrial fibrillation with rapid ventricular response (e.g., heart rate \> 120 bpm) * premature atrial or ventricular complexes of a frequency that will not allow adequate echocardiographic assessment * poor acoustic windows * inability to provide informed consent * any contraindication listed in the optison package insert (i.e., history of an allergic reaction)

Keywords: acute rejection, myocardial blood flow
neurodevelopmental outcome after persistent pulmonary hypertension of the newborn

Conditions: Persistent Pulmonary Hypertension of the Newborn

Summary: neonatal pulmonary hypertension is a rare but serious condition resulting from a lack of adaptation to extra-uterine life in some newborns. in the short term, the risk of death requires rapid and appropriate management of this transient pathology. in the long term, these newborns present a greater brain vulnerability, a consequence of the pathology itself with cerebral hypoxia but also invasive and aggressive therapies. although current scientific evidence indicates a correlation with the existence of neurological developmental disorders, the understanding of the long-term neurological outcome of these babies remains poorly documented. better knowledge of remote neuro-psychomotor development of the critical period


Eligibility criteria:
inclusion criteria: * all parenting authority holders of children aged 1 to 5 years, born after 34 weeks of amenorrhea and having been cared for neonatal pah in paediatric resuscitation exclusion criteria: * holders of parental authority who cannot answer the questionnaire because they do not speak french. * opposition of one of the two holders of parental authority * minor parental authority holders * holders of parental authority under safeguarding of justice, guardianship or guardianship * newborns with neonatal pah with an associated diagnosis of diaphragmatic hernia or cyanogenic congenital heart disease * newborns with neonatal pah not treated with nitrogen monoxide
clara: somatic and germline mechanisms that impact renal cancer immunotherapy

Conditions: Renal Cancer Metastatic

Summary: the study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on renal cell carcinoma (rcc) development and treatment (immunotherapy).

one hundred newly diagnosticated stage iv rcc patients will be recruited in the ribeirao preto medical school. patients will be treated with immune checkpoint inhibitors (ici) combination: nivolumab (3 mg/kg of body weight) plus ipilimumab (1 mg/kg) intravenously every three weeks for four doses, followed by nivolumab 480mg every four weeks, until progression, toxicity or complete two years of treatment. patients will be followed up for the clinical outcome (progression-free survival, best response, and overall survival). fresh-frozen primary tumor tissue will be collected for somatic genomic characterization. blood dna will be genotyped for the identification of common germline variation, as well as ancestry determination.

Eligibility criteria:
inclusion criteria: * renal cell carcinoma patient: histological confirmed clear cell tumor; * first-line metastatic treatment; * stage iv with at least one measured lesion; * fresh-frozen primary tumor tissue available; * no previous immunotherapy or tyrosine kinase inhibitor treatment; * all international metastatic rcc database consortium (imdc) risk score; * karnofsky performance scale (kps) \>=70; * \>=18 years old. exclusion criteria: * history of a known or suspected autoimmune disease; * any condition requiring systemic treatment with corticosteroids; * creatinine clearance \< 40ml/min; * alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \> 5 x uln; * pregnant women.

Keywords: renal cancer nivolumab ipilimumab immunotherapy molecular profiling
observational study to estimate the dry mouth in oab patients with solifenacin

Conditions: Overactive Bladder

Summary: a prospective, multicenter, observation study to estimate the dry mouth in oab patients with solifenacin

to estimate the dry mouth and their impact on the efficacy of the drug in overactive bladder patients with solifenacin

Eligibility criteria:
inclusion criteria: * 1) male or female patients with 20 years of age or older 2) clinical history of oab for at least 3 months prior to visit 2 3) more than 3 in total score and 2 in q 3 index from oabss questionnaire exclusion criteria: * 1) in clinical trial, female with pregnant, intent to become pregnant or breast-feeding 2)post-voided residual urine volume \> 150ml 3) a history of catheterization due to acute urinary retention 4) a history of pelvic surgery within 6 months 5) 6) 7) a history of neurovascular disease such as parkinson's disease, cerebral vascular disease, spinal injury or multiple sclerosis 8)patients with indwelling catheter or intermittent catheterization 9) active or recurrent (\>3 episodes per year) urinary tract infection 10) the use of the following medication at least 2 weeks * anticholinergics * tricyclic antidepressants,anti-epilepsy drug, anti-parkinson's disease drug, anti-arrythmia drug type i * chlorpromazine, thioridazine, piperazine * mao inhibitor 11) patient is currently taking or has taken within the past 4 weeks alpha-blocker for the treatment of benign prostatic hypertrophy 12) patient is currently taking or has taken within the past 8 weeks 5ari or estrogen medication 13) patient is currently using or has used medications with known activities as inhibitors or inducers of cytochrome p4503a4 (cyp3a4)